Serum Biomarker of Plaque Vulnerability and Contrast Ultrasound of Carotid Artery
August 22, 2014 updated by: Weon Kim, Kyunghee University Medical Center
Can Serum Biomarker of Plaque Vulnerability be Identified Through the Contrast-enhanced Ultrasound of Carotid Artery
No serum biomarker has qualified for clinical use until now.
However several biomarkers, especially markers of inflammatory or proteolytic activity seem to promising in the identification of vulnerable plaques.
Moreover, recent study confirmed that contrast-enhanced ultrasound imaging(CEUS) can visualize intraplaque neovascularization and represent the plaque vulnerability.
In this study we try to identify indicators through analysis of the relationship between plaque neovascularization seen by CEUS and well known biomarkers such as serum matrix metalloproteinase(MMP)-2, MMP-9, cathepsin family(L,S,V), cystatin C, lipoprotein phospholipase A2, and hs-crp
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 130-872
- Division of Cardiology, Department of Internal Medicine, Kyung Hee University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients were selected from those who admitted due to chest pain and underwent carotid duplex ultrasound examination at KyungHee university medical center, Seoul, South Korea.
Description
Inclusion Criteria:
- patients with carotid plaques size more than 2mm by carotid ultrasound
Exclusion Criteria:
- known allergy to albumin, or to the ultrasound contrast agent
- the patients with history of carotid endarterectomy and carotid stent
- acute myocardial infarction, cardiogenic shock
- connective tissue disease and malignancy
- creatinine clearance lower than 30ml/min and the history of dialysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Peak plasma concentration of Biomarker that is statistically significant different according to the presence of intraplaque neovascularization on contrast enhanced ultrasound of carotid artery
Time Frame: after performing contrast enhanced ultrasound of carotid artery, upto 3 hospital days
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after performing contrast enhanced ultrasound of carotid artery, upto 3 hospital days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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the number of the patients with history of cardiovascular event including myocardial infarction, cerebral vascular event and peripheral arterial disease and the number of 1 year clinical outcome of cardiovascular event
Time Frame: after performing contrast enhanced ultrasound of carotid artery, upto 1 year clinical follow up
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after performing contrast enhanced ultrasound of carotid artery, upto 1 year clinical follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
March 23, 2013
First Submitted That Met QC Criteria
April 24, 2013
First Posted (Estimate)
April 29, 2013
Study Record Updates
Last Update Posted (Estimate)
August 25, 2014
Last Update Submitted That Met QC Criteria
August 22, 2014
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INCA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.